5.1.1 Definition of Adverse Event An AE is defined as any untoward medical occurrence such as a sign(s), symptom (s), and/or laboratory finding(s) concurrent with the use of a drug in humans. AEs include worsening of any baseline symptoms. The event may/may not necessarily have a causal relationship with the administration of the drug. AEs may be reported by the subject, or detected by the investigator, or other competent observer. The investigator will also evaluate any change in laboratory values. If the investigator determines a laboratory abnormality to be clinically significant, it is considered a laboratory AE; however, if the laboratory value abnormality is consistent with a current diagnosis, it may be documented accordingly.